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AzTrials

COVID-19 PneumoniaPhase 2NCT05033847

Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cells) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above

A Phase 2 study testing Recombinant COVID-19 Vaccine (CHO cell) and COVID-19 vaccine (Vero cells) in people with COVID-19 Pneumonia and Coronavirus Infections, run by National Vaccine and Serum Institute, China at 1 site in United Arab Emirates.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is randomized, blinded and controlled design. Among the randomly selected subjects who have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell), based on a step-wise approach, the subjects will receive one dose of recombinant COVID-19 vaccine sequentially at different shedules of 1-3… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19 Pneumonia, Coronavirus Infections
What is being tested?
Recombinant COVID-19 Vaccine (CHO cell) and COVID-19 vaccine (Vero cells)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,800 participants
Where
1 siteUnited Arab Emirates
Study dates
12 Sep 2021to Jan 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age range: populations aged 18 years and above;
  • Judged by the investigator that the health condition is well after inquiry and physical examination;
  • Vaccinated with 2 doses of CNBG inactivated COVID-19 vaccine according to the product insert;
  • Female subjects who are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 6 months after enrolment. Effective contraceptive measures have been taken within 2 weeks before inclusion.
  • During the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan; Self has ability to understand the study procedures, the informed consent \& voluntarily sign an informed consent form and is able to comply with the requirements of the clinical study protocol.

Who cannot join

  • Confirmed cases, suspected cases or asymptomatic cases of COVID-19;
  • With a history of SARS and MERS infection (self-report, on-site inquiry);
  • Has vaccinated with any vaccine other than one or more doses of CNBG inactivated COVID-19 vaccine;
  • Axillary temperature ≥ 37.3 ℃ (forehead temperature ≥ 37.8 ℃);
  • Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known components of recombinant COVID-19 vaccine;
  • Allergic to any component of the study vaccine (e.g. aluminum, histidine, etc.)
Show all 19Show fewer
  • Known or suspected diseases include：Severe respiratory diseases, severe liver and kidney diseases, hypertension (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 90 mmHg), diabetic complications, malignant tumors, various acute diseases or acute attacks of chronic diseases;
  • Has been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
  • Has a history of convulsions, epilepsy, encephalopathy，long term history of alcohol and drug abuse, history of thyroidectomy, infectious diseasesor mental illness or family history（lineal）;
  • With Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc.;
  • Has a history of coagulation dysfunction (e.g. coagulation factors deficiency and coagulation diseases);
  • Absence of spleen or splenectomy, functional absence of spleen caused by any condition
  • Anti -TB (TB) treatment is under way.
  • Patients receiving immunoenhancement or inhibitor therapy within 3 months (continuous oral or IV administration for more than 14 days);
  • Received other vaccines within 14 days before vaccination；
  • Received blood products before within 3 months before vaccination;
  • Received other investigational drugs within 6 months before vaccination;
  • Plan to move before the end of the study or leave the local area for a long time during the scheduled study visit
  • Other circumstances judged by investigators that are not suitable for this clinical trial

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site

  • Sheikh Khalifa Medical City

    SEHA, Abu Dhab, 519000

Other trials in United Arab Emirates

About this study

This is randomized, blinded and controlled design. Among the randomly selected subjects who have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell), based on a step-wise approach, the subjects will receive one dose of recombinant COVID-19 vaccine sequentially at different shedules of 1-3 months, 3-6 months and ≥ 6 months after two doses of vaccination, and the subjects vaccinated at different schedules will be randomly assigned to different sequential immunization groups. At the same time, each sequential immunization group will be matched with a control group with the inactivated COVID-19 vaccine (vero cells) as the booster dose.

Being tested
Recombinant COVID-19 Vaccine (CHO cell), COVID-19 vaccine (Vero cells)
Keywords
COVID-19
Medical subject headings
Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant COVID-19 Vaccine (CHO cell)Biological

    Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell) in the deltoid muscle of the upper arm

  • COVID-19 vaccine (Vero cells)Biological

    Intramuscular injection of Recombinant COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm

Study groups in NCT05033847
Study groupRoleWhat they receive
Subject last vaccination time is within 30-90 daysExperimentalSubject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time is within 30-90 days
Receives: Biological: Recombinant COVID-19 Vaccine (CHO cell); Biological: COVID-19 vaccine (Vero cells)
Subject last vaccination time is within 91-180 daysExperimentalSubject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time is within 91-180 days
Receives: Biological: Recombinant COVID-19 Vaccine (CHO cell); Biological: COVID-19 vaccine (Vero cells)
Subject last vaccination time more than 181 daysExperimentalSubject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time more than 181 days
Receives: Biological: Recombinant COVID-19 Vaccine (CHO cell); Biological: COVID-19 vaccine (Vero cells)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. GMT of anti- SARS-CoV-2 neutralizing antibody

    Measured: 14th day after vaccination

  2. GMT of anti- SARS-CoV-2 neutralizing antibody

    Measured: 28th day after vaccination

  3. 4-fold rise of anti- SARS-CoV-2 neutralizing antibody

    Measured: 14th day after vaccination

  4. 4-fold rise of anti- SARS-CoV-2 neutralizing antibody

    Measured: 28th day after vaccination

Secondary outcomes (16)

  1. GMT of anti- SARS-CoV-2 neutralizing antibody

    Measured: before vaccination

  2. GMT of anti-SARS-CoV-2 IgG antibody

    Measured: 28th day after vaccination

  3. 4-fold rise of anti- SARS-CoV-2 neutralizing antibody

    Measured: before vaccination

  4. 4-fold rise of anti- SARS-CoV-2 neutralizing antibody

    Measured: 28th day after vaccination

  5. GMI of anti-SARS-CoV-2 IgG antibody

    Measured: before vaccination

  6. GMI of anti-SARS-CoV-2 IgG antibody

    Measured: 28th day after vaccination

  7. Proportion of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64

    Measured: before vaccination

  8. Proportion of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64

    Measured: 28th day after vaccination

  9. The incidence and serverity of any adverse reactions

    Measured: within 30 minutes after vaccination

  10. The incidence and serverity of solicited adverse events

    Measured: within 30 minutes after vaccination

  11. The incidence and severity of adverse reactions

    Measured: within 0-7 days after vaccination

  12. The incidence and serverity of solicited adverse events

    Measured: within 0-7 days after vaccination

  13. The incidence and severity of unsolicited adverse reactions

    Measured: within 8-30 days after vaccination

  14. The incidence and serverity of solicited adverse events

    Measured: within 8-30 days after vaccination

  15. The incidence of SAE observed

    Measured: after vaccination and up to 6 months after full course of immunization

  16. The incidence of AESI observed

    Measured: after vaccination and up to 6 months after full course of immunization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2021
  2. Study start12 Sep 2021
  3. Primary completionNov 2023 (estimated)
  4. Study completionJan 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05033847
Sponsor's protocol ID
CNBG 2021001
Status last verified
Jan 2023
First submitted
30 Aug 2021
Last updated
2 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Recombinant COVID-19 Vaccine (CHO cell) and COVID-19 vaccine (Vero cells) in people with COVID-19 Pneumonia and Coronavirus Infections, run by National Vaccine and Serum Institute, China at 1 site in United Arab Emirates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

GMT of anti- SARS-CoV-2 neutralizing antibody (time frame: 14th day after vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05033847.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.

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